Digital insomnia treatment in Australian pharmacy settings.

This randomised waitlist-controlled implementation trial will investigate the feasibility and effectiveness of providing Australian pharmacists access to an online referral pathway, to refer their patients to an online Cognitive Behavioural Therapy for Insomnia (CBTi) program. Pharmacists, and a selection of eligible patients they refer to the study will be recruited. Patients referred to the trial by pharmacists will undergo online screening and consent. Eligible patients will complete a baseline questionnaire battery before being randomised 1:1 to a 5-session online CBTi program, or waitlist education-control. Patients will complete outcome questionnaires at 8, 16, and 24 weeks. The waitlist control group will be provided access to the online CBTi program after the 8-week follow-up. With consent from patients, pharmacists and general practitioners will be provided a follow-up report of patient progress at 8, 16, and 24 week follow-up. GP follow-up reports will be generated by the study team and will include participant-level information on; change in insomnia symptoms before and after treatment, sleeping pill use, and date of next follow-up report. Information about the online CBTi program appears below. Rationale: Cognitive behavioural therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia (Qaseem et al., 2016, Ann Intern Med). Very few Australian patients with insomnia ever access CBTi (Miller et al., 2017, JCSM). This project aims to test the effectiveness of a dCBTi intervention in the Australian pharmacy settings. Type: Non-drug, online, interactive. Setting/location: Online, any location in Australia. Duration: 5 x 20 minute online sessions, delivered over 5 consecutive weeks. Protocol: This program is based on CBTi, the recommended treatment for insomnia (e.g. Qaseem et al., 2016, Ann Intern Med, DOI: 10.7326/M15-2175). It is an interactive online version of a brief CBTi protocol described in an scientific article in the Australian Journal of General Practice (Sweetman et al., 2021, AJGP, doi: 10.31128/AJGP-04-20-5391). Content: Each session will be administered online (computer or mobile phone). Each session will contain videos, text, and images. Patients will be asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants will receive tailored therapy recommendations during each weekly session (see Sweetman et al., 2021, Aus J General Practice for tailored therapy recommendations). Immediately after each session is completed, participants will receive an automated follow-up email with session-specific 'follow-up' information and tailored therapy recommendations including recommended bedtime window (approximate reading time: 15 minutes). Participants will receive another automated email one week later with a link to start each subsequent session. Videos are presented by researchers, psychologists, and sleep technicians, each with extensive experience (>8 years) in the management of insomnia. Tailoring / personalisation: Therapy recommendations will be tailored to participant's insomnia symptoms at baseline and weekly changes in symptoms throughout the program. Bedtime Restriction Therapy (initial restriction of time in bed to consolidate sleep, and subsequent gradual extension of time in bed) is a core component of CBTi. Bedtime restriction recommendations will be tailored to the specific sleep/wake information that participants provide. Primary therapeutic components: Information about sleep, Relaxation therapy, Cognitive restructuring, Bedtime restriction therapy, Stimulus Control Therapy. Adherence assessment: Adherence will be defined as the number of participants commencing each of the 5 online sessions. This information is automatically collected through the online system.